CtDNA as a Novel Biomarker of Treatment Efficacy in Patients With Ovarian Cancer

Recruiting

• Conditions: High-grade Serous Ovarian Cancer; Circulating Tumor DNA

• Registration Number: NCT05027828
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

This study is a prospective observational clinical trial. Patients who were diagnosed and treated for the first time were enrolled and their surgical pathology was confirmed to be high-grade serous ovarian cancer. At the same time, these patients will receive first-line maintenance treatment with PARP inhibitors after traditional chemotherapy. During the trial period, patients' plasma will be collected before surgery, after chemotherapy, during targeted maintenance therapy, and during disease progression, and ctDNA-specific genomes will be detected, and clinical data will be collected over the same period. It is expected that specific ctDNA can be used to predict the efficacy of PARP inhibitors in patients with ovarian cancer, and to detect the recurrence of the disease early.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-25
• Study First Posted: 2021-08-30
• Study Start: 2021-09-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-01
• Last Update Posted: 2024-12-04
• Primary Completion: 2027-04-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Ovarian cancer first diagnosed and treated;
2. Pathologically confirmed as epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer;
3. The stage of the disease is II-IV, and surgery will be performed after evaluation;
4. Age ≥ 18 years old;
5. Subjects and their families fully understand the research plan and sign an informed consent form.

Exclusion Criteria

1. Pathologically confirmed as non-epithelial ovarian cancer;
2. Surgical treatment cannot be performed after evaluation;
3. Malignant tumors found in other parts of the study were found within five years before enrollment or at the time of enrollment;
4. Patients who do not agree to use clinical first-line targeted drugs;
5. Severe mental illness;
6. Severe cardiovascular disease, uncontrollable infection, or other uncontrollable comorbid diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival	about 36 months after using PARP inhibitors	To determine the different prognosis of patients after using the PARP inhibitor for first-line maintenance treatment, at the same time, the plasma will be collected and tested for ctDNA before using the PARP inhibitor, during use and when the disease is progressing.

Secondary Outcome Measures

Name	Time	Method
Overall survival	about over 5 years after using PARP inhibitors
Objective response rate	36 months after using PARP inhibitors	To evaluate the general response of patients with ovarian cancer to PARP inhibitors

Trial Locations

Locations (1)

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China